archetype (adl_version=1.4; uid=f80cfa89-3987-4f84-9e65-6bdc3721c671)
	openEHR-EHR-OBSERVATION.ichom_lpc_complications.v0

concept
	[at0000]	-- ICHOM LPC Complication
language
	original_language = <[ISO_639-1::en]>
description
	original_author = <
		["name"] = <"Hildegard Franke">
		["organisation"] = <"freshEHR Clinical Informatics Ltd.">
		["email"] = <"hildi@freshehr.com">
		["date"] = <"2016-08-08">
	>
	details = <
		["en"] = <
			language = <[ISO_639-1::en]>
			purpose = <"Local archetype to capture acute complications of treatment, such as Clavien grade and CTCAE grade.">
			use = <"For use in ICHOM LPC dataset to capture details of acute complications of treatment.">
			keywords = <"complication", "clavien", "ICHOM", "prostate", "cancer">
			misuse = <"">
			copyright = <"© Clinical Models UK">
		>
	>
	lifecycle_state = <"in_development">
	other_contributors = <>
	other_details = <
		["licence"] = <"This work is licensed under the Creative Commons Attribution-ShareAlike 3.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/.">
		["custodian_organisation"] = <"UK Clinical Models">
		["current_contact"] = <"Hildegard Franke, freshEHR Clinical Informatics Ltd.<hildi@freshehr.com>">
		["original_namespace"] = <"uk.org.clinicalmodels">
		["original_publisher"] = <"UK Clinical Models">
		["custodian_namespace"] = <"uk.org.clinicalmodels">
		["MD5-CAM-1.0.1"] = <"39793F9A6BE6E916077821384644B121">
		["build_uid"] = <"2099b598-3a1d-4b58-a061-00bc448e41a0">
		["revision"] = <"0.0.1-alpha">
	>

definition
	OBSERVATION[at0000] matches {	-- ICHOM LPC Complication
		data matches {
			HISTORY[at0001] matches {	-- Event Series
				events cardinality matches {1..*; unordered} matches {
					POINT_EVENT[at0002] occurrences matches {0..1} matches {	-- Point in time
						data matches {
							ITEM_TREE[at0003] matches {	-- Tree
								items cardinality matches {0..*; unordered} matches {
									ELEMENT[at0004] occurrences matches {0..1} matches {	-- Clavien complication
										value matches {
											0|[local::at0005], 	-- No
											1|[local::at0006], 	-- Yes, Grade 3
											2|[local::at0007]  	-- Yes, Grade 4
										}
									}
									ELEMENT[at0008] occurrences matches {0..1} matches {	-- CTCAE Grade 3 or 4 complication
										value matches {
											DV_BOOLEAN matches {
												value matches {True, False}
											}
										}
									}
									ELEMENT[at0010] occurrences matches {0..*} matches {	-- CTCAE domain and grade
										value matches {
											DV_CODED_TEXT matches {
												defining_code matches {
													[local::
													at0011, 	-- 0 = No grade 3 or 4 toxicity
													at0012, 	-- 1 = Fatigue grade 3
													at0013, 	-- 2 = Fatigue grade 4
													at0014, 	-- 3 = Dermatitis grade 3
													at0015, 	-- 4 = Dermatitis grade 4
													at0016, 	-- 5 = Diarrhea grade 3
													at0017, 	-- 6 = Diarrhea grade 4
													at0018, 	-- 7 = Abdominal pain grade 3
													at0019, 	-- 8 = Abdominal pain grade 4
													at0020, 	-- 9 = Rectal mucositis grade 3
													at0021, 	-- 10 = Rectal mucositis grade 4
													at0022, 	-- 11 = Proctitis grade 3
													at0023, 	-- 12 = Proctitis grade 4
													at0024, 	-- 13 = Hot flashes grade 3
													at0025, 	-- 14 = Hot flashes grade 4
													at0026, 	-- 15 = Cystitis non-infective grade 3
													at0027, 	-- 16 = Cystitis non-infective grade 4
													at0028, 	-- 17 = Urinary retention grade 3
													at0029, 	-- 18 = Urinary retention grade 4
													at0030, 	-- 19 = Other grade 3 (free text)
													at0031]	-- 20 = Other grade 4 (free text)
												}
											}
										}
									}
									allow_archetype CLUSTER[at0009] occurrences matches {0..*} matches {	-- CTCAE domain and grade
										include
											archetype_id/value matches {/.*/}
									}
								}
							}
						}
					}
				}
			}
		}
		protocol matches {
			ITEM_TREE[at0032] matches {	-- Tree
				items cardinality matches {0..*; unordered} matches {
					allow_archetype CLUSTER[at0033] occurrences matches {0..*} matches {	-- Extension
						include
							archetype_id/value matches {/.*/}
					}
				}
			}
		}
	}


ontology
	term_definitions = <
		["en"] = <
			items = <
				["at0000"] = <
					text = <"ICHOM LPC Complication">
					description = <"Acute complications of treatment.">
				>
				["at0001"] = <
					text = <"Event Series">
					description = <"@ internal @">
				>
				["at0002"] = <
					text = <"Point in time">
					description = <"A specific date and/or time which may be explicitly defined in a template or at run-time.">
				>
				["at0003"] = <
					text = <"Tree">
					description = <"@ internal @">
				>
				["at0004"] = <
					text = <"Clavien complication">
					description = <"Indication whether patient experienced a Clavien grade III-V complication.">
				>
				["at0005"] = <
					text = <"No">
					description = <"Patient did not experience Grade 3 or 4 complication.">
				>
				["at0006"] = <
					text = <"Yes, Grade 3">
					description = <"Patient experienced Grade 3 complication.">
				>
				["at0007"] = <
					text = <"Yes, Grade 4">
					description = <"Patient experienced Grade 4 complication.">
				>
				["at0008"] = <
					text = <"CTCAE Grade 3 or 4 complication">
					description = <"Indication whether the patient experienced a CTCAE grade 3 or 4 complication during treatment with radiation therapy or within the first 6 months following the completion of radiation therapy.">
				>
				["at0009"] = <
					text = <"CTCAE domain and grade">
					description = <"Statement of CTCAE domain and grade if complication was experienced.">
					comment = <"The CTCAE defines Grade 3 and 4 complications for the following categories as follows:   
Fatigue
  - Grade 1: Fatigue relieved by rest
  - Grade 2: Fatigue not relieved by rest; limiting instrumental ADL
  - Grade 3: Fatigue not relieved by rest, limiting self care ADL
  - Grade 4: N/A
Dermatitis radiation
  - Grade 1: Faint erythema or dry desquamation
  - Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
  - Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
  - Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
Diarrhea
  - Grade 1: Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline
  - Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline
  - Grade 3: Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL
  - Grade 4: Life-threatening consequences; urgent intervention indicated
Abdominal pain
  - Grade 1: Mild pain
  - Grade 2: Moderate pain; limiting instrumental ADL
  - Grade 3: Severe pain; limiting self care ADL
  - Grade 4: N/A
Rectal mucositis
  - Grade 1: Asymptomatic or mild symptoms; intervention not indicated
  - Grade 2: Symptomatic; medical intervention indicated; limiting instrumental ADL
  - Grade 3: Severe symptoms; limiting self care ADL
  - Grade 4: Life-threatening consequences; urgent operative intervention indicated
Proctitis
  - Grade 1: Rectal discomfort, intervention not indicated
  - Grade 2: Symptoms (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL
  - Grade 3: Severe symptoms; fecal urgency or stool incontinence; limiting self care ADL
  - Grade 4: Life-threatening consequences; urgent intervention indicated
Hot flashes
  - Grade 1: Mild symptoms; intervention not indicated
  - Grade 2: Moderate symptoms; limiting instrumental ADL
  - Grade 3: Severe symptoms; limiting self care ADL
  - Grade 4: N/A
Cystitis non-infective
  - Grade 1: Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence
  - Grade 2: Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL
  - Grade 3: Gross hematuria; transfusion, IV medications or hospitalization indicated; elective endoscopic, radiologic or operative intervention indicated
  - Grade 4: Life-threatening consequences; urgent radiologic or operative intervention indicated
Urinary retention
  - Grade 1: Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual
  - Grade 2: Placement of urinary, suprapubic or intermittent catheter placement indicated; medication indicated
  - Grade 3: Elective operative or radiologic intervention indicated; substantial loss of affected kidney function or mass
  - Grade 4: Life-threatening consequences; organ failure; urgent operative intervention indicated.">
				>
				["at0010"] = <
					text = <"CTCAE domain and grade">
					description = <"Statement about CTCAE domain and grade experienced during radiation therapy.">
				>
				["at0011"] = <
					text = <"0 = No grade 3 or 4 toxicity">
					description = <"Patient has not experienced grade 3 or 4 toxicity.">
				>
				["at0012"] = <
					text = <"1 = Fatigue grade 3">
					description = <"Patient has experienced grade 3 fatigue.">
				>
				["at0013"] = <
					text = <"2 = Fatigue grade 4">
					description = <"Patient has experienced grade 4 fatigue.">
				>
				["at0014"] = <
					text = <"3 = Dermatitis grade 3">
					description = <"Patient has experienced grade 3 dermatitis.">
				>
				["at0015"] = <
					text = <"4 = Dermatitis grade 4">
					description = <"Patient has experienced grade 4 dermatitis.">
				>
				["at0016"] = <
					text = <"5 = Diarrhea grade 3">
					description = <"Patient has experienced grade 3 diarrhoea.">
				>
				["at0017"] = <
					text = <"6 = Diarrhea grade 4">
					description = <"Patient has experienced grade 4 diarrhoea.">
				>
				["at0018"] = <
					text = <"7 = Abdominal pain grade 3">
					description = <"Patient has experienced grade 3 abdominal pain.">
				>
				["at0019"] = <
					text = <"8 = Abdominal pain grade 4">
					description = <"Patient has experienced grade 4 abdominal pain.">
				>
				["at0020"] = <
					text = <"9 = Rectal mucositis grade 3">
					description = <"Patient has experienced grade 3 rectal mucositis.">
				>
				["at0021"] = <
					text = <"10 = Rectal mucositis grade 4">
					description = <"Patient has experienced grade 4 rectal mucositis.">
				>
				["at0022"] = <
					text = <"11 = Proctitis grade 3">
					description = <"Patient has experienced grade 3 proctitis.">
				>
				["at0023"] = <
					text = <"12 = Proctitis grade 4">
					description = <"Patient has experienced grade 4 proctitis.">
				>
				["at0024"] = <
					text = <"13 = Hot flashes grade 3">
					description = <"Patient has experienced grade 3 hot flushes.">
				>
				["at0025"] = <
					text = <"14 = Hot flashes grade 4">
					description = <"Patient has experienced grade 5 hot flushes.">
				>
				["at0026"] = <
					text = <"15 = Cystitis non-infective grade 3">
					description = <"Patient has experienced grade 3 non-infective cystitis.">
				>
				["at0027"] = <
					text = <"16 = Cystitis non-infective grade 4">
					description = <"Patient has experienced grade 4 non-infective cystitis.">
				>
				["at0028"] = <
					text = <"17 = Urinary retention grade 3">
					description = <"Patient has experienced grade 3 urinary retention.">
				>
				["at0029"] = <
					text = <"18 = Urinary retention grade 4">
					description = <"Patient has experienced grade 4 urinary retention.">
				>
				["at0030"] = <
					text = <"19 = Other grade 3 (free text)">
					description = <"Patient has experienced other grade 3.">
				>
				["at0031"] = <
					text = <"20 = Other grade 4 (free text)">
					description = <"Patient has experienced other grade 4.">
				>
				["at0032"] = <
					text = <"Tree">
					description = <"@ internal @">
				>
				["at0033"] = <
					text = <"Extension">
					description = <"Additional information required to capture local context or to align with other reference models/formalisms.">
					comment = <"e.g. Local hospital departmental infomation or additional metadata to align with HL7 or CDISC equivalents.">
				>
			>
		>
	>